An Open-label Study to Evaluate Contraceptive Efficacy and Safety of the Transdermal Contraceptive System of Norelgestromine and Ethinyl Estradiol

NCT ID: NCT00307632

Last Updated: 2014-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 580 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-02-28
• Study Completion Date: 2004-12-31

Brief Summary

The purpose of this study is to evaluate the contraceptive efficacy, safety, cycle control, compliance, and subject satisfaction of the transdermal contraceptive system, norelgestromine and ethinyl estradiol (NLGM / EE).

Detailed Description

A multicenter, open label, descriptive study. Five hundred requiring contraception will receive the weekly transdermal contraceptive patch for 6 cycles. At the baseline and after the 1st, 3rd and 6th cycles, satisfaction with the method will be assessed. The contraceptive efficacy will be assessed by the Pearl Index and by life table analysis. To assess satisfaction with the weekly transdermal contraceptive patch, this method will be compared to the previous contraceptive method. Adhesion, cycle control, safety and efficacy are secondary outcomes. Treatment duration: 6 cycles (4 weeks each). The subject will wear a 20 cm2 contraceptive transdermal patch for one full week, apply a fresh patch for week 2, and a third patch for week 3. The fourth week will be patch-free. Each patch deliveries 150 mcg of NLGM and 20 mcg of EE per day.

Conditions

Contraception

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Norelgestromine (NLGM)/Ethinyl Estradiol (EE)

Group Type: EXPERIMENTAL

Norelgestromine (NLGM)/ethinyl estradiol (EE)

Intervention Type: DRUG

Participants will apply a 20 centimeter square (cm\^2) contraceptive transdermal patch on the skin for 1 full week, and then apply a fresh patch for Week 2, and a third patch for Week 3. The fourth week will be patch-free. Each patch delivers 150 microgram (mcg) of NLGM and 20 mcg of EE per day. The treatment duration is of 6 cycles (4 weeks each).

Interventions

Norelgestromine (NLGM)/ethinyl estradiol (EE)

Participants will apply a 20 centimeter square (cm\^2) contraceptive transdermal patch on the skin for 1 full week, and then apply a fresh patch for Week 2, and a third patch for Week 3. The fourth week will be patch-free. Each patch delivers 150 microgram (mcg) of NLGM and 20 mcg of EE per day. The treatment duration is of 6 cycles (4 weeks each).

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy adult females who meet the following selection criteria: Have regular menses occuring every 25-35 days
• Acceptable body mass (< 30) and the weight is < 90 kg
• Has completed her last term pregnancy at least 4 months prior to study admission, is not lactating and has at least one normal menstrual period since her last pregnancy and not breast feeding
• Has a sitting blood pressure systolic < 140 mm/Hg and diastolic < 90 mm/Hg.

Exclusion Criteria

• Has not received a DepoProvera injection or any other depot hormone injection within six months prior to the screening visit
• Has not used / or in current use of barbiturates, antiepileptics, rifampin, griseofulvin, Hypericum perforatum, or other hepatic enzyme-inducing drugs within 30 days prior to the pre-study visit
• Has not a uncontrolled disorder
• No women over the age 35 who smoke.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Janssen-Cilag Farmaceutica Ltda.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen-Cilag Farmaceutica Ltda. Clinical Trial

Role: STUDY_DIRECTOR

Janssen-Cilag Farmaceutica Ltda.

Locations

Belo Horizonte, , Brazil

Botucatu, , Brazil

Brasília, , Brazil

Curitiba, , Brazil

Goiânia, , Brazil

Porto Alegre, , Brazil

Ribeirão Preto, , Brazil

São Paulo, , Brazil

Sorocaba, , Brazil

Mexico City, , Mexico

México, , Mexico

Monterrey, , Mexico

Countries

Brazil; Mexico

Other Identifiers

NRGEEPCON4015

Identifier Type: OTHER

Identifier Source: secondary_id

CR002962

Identifier Type: -

Identifier Source: org_study_id